Expanding Access to ART in Thailand: Achieving Treatment Benefits while Promoting Effective Prevention Joint Study by Thailand Ministry of Public Health and The World Bank* EXECUTIVE SUMMARY Thailand is in the vanguard of developing countries that are seeking to provide anti-retroviral therapy as the standard of care to large numbers of people with symptomatic HIV disease. As of February 2005, some 52,593 people living with HIV/AIDS in Thailand had received ART through the National Access to Antiretroviral Program for People Living with HIV/AIDS (or NAPHA), and approximately 8,000 are estimated to have access to ART through the Social Security Scheme. The Royal Thai Government’s objective is to provide ART to 80,000 people living with HIV/AIDS by end-2005. The purpose of this report is to advise the Thai government and Thai society at large on the full range of benefits, costs and consequences likely to result from decision to expand public provision of ART through NAPHA and to assist with the design of implementation policies that achieve maximum treatment benefits, while promoting prevention and maintaining financial sustainability. I. Background Provision of ART in Thailand The first case of AIDS in Thailand was reported in September 1984. Since then more than one million Thais have been infected with HIV and, of these, more than 400,000 have died. In 2004, some 572,500 Thais were estimated to be living with HIV/AIDS (Table 1). Among these, some 49,500 will develop serious AIDS-related illnesses this year, and about the same will die of * Study team includes Thanprasertsuk S., Lertpiriyasuwat C., (MOPH); Revenga A., Over M., Masaki E., (World Bank); Brown T., Peerapatanapokin W., (East-West Center); Tangcharoensathien V., Lertiendumrong J., (IHPP); Gold J., Duncombe C., (HIV-NAT, Thai Red Cross), Wilson D., (MSF), Phongphit S., (Village Foundation). ** For questions or clarifications, please contact arevenga@worldbank.org or emasaki@worldbank.org 1 AIDS-related complications. It is also estimated that 19,500 new infections will occur this year (compared to 143,000 new infections in 1990, and 23, 676 new infection in 2002). Table 1: Estimated Cumulative Numbers of HIV/AIDS in the year 2004 Total HIV infections (adults and children) Total deaths (adults and children) People living with HIV Projected new HIV infections in 2004 Projected new AIDS cases in 2004 Source: Working Group on HIV/AIDS Projections for 2004. 1,074,155 501,600 572,484 19,471 49,542 The Royal Thai Government and Thai Figure 1: Access to HIV/AIDS Medical Care society have demonstrated a strong commitment to providing comprehensive Access to HIV/AIDS Medical Care care and support to persons living with in Thailand Thailand HIV/AIDS (PHAs), but it is only recently Treatment of common opportunistic infections as TB, PCP, cryptococcal meningitis etc. that they have been able to provide antiretroviral therapy (ART) to large Monotherapy (AZT) 1992- 1995 numbers of people with symptomatic HIV Dual therapy (AZT+ddI and AZT+ ddC) 1995 - 1996 (Figure 1). The availability of a HIV Clinical Research Network (dual and triple ARV) 1997-2000 domestically-produced triple drug combination (GPO-vir 1) at affordable Access to care (triple ARV and OI prevention and treatment) since 2000 prices (about 1,200 Baht or US$30 per National Access to ARV for PWHA since 2003 month) has opened the door for many PHAs, who could previously not afford it, to access ART, and has allowed the Ministry of Public Health to roll-out a large-scale campaign to provide triple-drug ART as standard care. As a result, the number of PHAs on ART has increased sharply from about 3,000 at the start of 2002 to 27,000 by end-2003, and to 52,593 by February 2005. The program is financed in part by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), and in part with government budget. The number of treatment sites increased from 112 in 2001 to 462 in early-2003, and to 841 by February 2005. Table 2 shows the evolution of estimated cases of PHAs, AIDS cases, and access to public ART in Thailand. As of end-2004, over 80% of those living with AIDS had access to public ART –a remarkable achievement Table 2: Estimated cases of people living with HIV/AIDS, AIDS cases, reported AIDS cases in public hospitals, and access to public ART 1997 1998 1999 2000 2001 2002 2003 2004 751,235 740,349 719,765 649,564 665,344 635,057 603,942 572,484 Living with HIV/AIDS 59,752 65,333 68,311 68,677 67,057 64,832 62,871 61,394 Living with AIDS 1,095* 1,095* 1,095* 2,095* 2,095* 8,341* 27,158 52,593^ Patients in public ART 1.8% 1.7% 1.6% 3.1% 3.1% 12.9% 43.2% 81.4% % of AIDS cases in public ART 4.1% 4.0% 4.0% 4.5% 8.5% 35.5% 122.6% % of reported AIDS in public ART Source: The Thai Working Group on HIV/AIDS Projection (2001), Clinical Background Paper (2004), and MOPH (2004) * Source: Follow-up to the Declaration of Commitment of HIV/AIDS (UNGASS) Country Report (2002) ^ Figure for February 2005. 1 GPO-vir is a single tablet 3 drug combination regimen (d4T+3TC+Nevirapine) produced by the Government Pharmaceutical Organization (GPO). 2 Benefits of Prior Prevention Efforts Successful implementation of NAPHA poses a significant challenge to the Royal Thai government and Thai society. In a few years, as AIDS patients live longer with ART, the health system will need to provide care not only to 10,000-20,000 new cases per year, but also to most of those whose lives have been significantly prolonged by ART. Given the commitment across all segments of Thai society, the country’s significant health system capacity, and the availability of internal and external financing, Thailand has good prospects for meeting this challenge. Its ability to even contemplate providing care to all those who need it, however, rests on the success of its past prevention efforts. 20 10 20 05 20 00 19 95 19 90 19 85 Current HIV Infections in millions In the absence of such past Figure 2: Importance of Prior Prevention Efforts successful national prevention efforts, HIV infections –and Thailand – Enormous current benefits of hence AIDS cases —today would prior prevention efforts be much higher than they actually 10 are (Figure 2). We have Red line represents what estimated that in the absence of might have been if 8 such efforts, Thailand would have behaviors had not changed 7.7 million HIV cases and 6 Infections 850,000 AIDS cases in 2005, prevented 4 roughly 14 times more of each than exist in reality. If we 2 suppose that Thailand would try 0 to offer ART to all of this much larger number of AIDS patients, its budget requirements would Baseline No Intervention also be 14 times greater and would continue to grow over the Source: East-West Center and Thai Working Group projections, 2001 next decade. Thanks to its substantial prevention efforts over the decade from 1991 through 2002, Thailand has avoided the need to spend an additional $18.6 billion (745 billion baht) on treatment over the decade through 2012. During the 1990s Thailand spent more than most countries on its HIV/AIDS program. Its total budget expenditures on prevention and treatment combined over this period was a substantial $434 million in 2002 dollars (17.3 billion baht). However, by averting the need to spend $18.6 billion dollars (745 billion baht) over the subsequent decade, each dollar (or baht) invested in the 1990s saved 43 dollars (or baht) in needed treatment expenditure in the subsequent decade. It is doubtful than any other Thai government investment achieved such a high rate benefit-cost ratio. The finance ministries of countries like India and China, where the HIV/AIDS epidemic is at an earlier stage, should be aware of the high return to HIV/AIDS prevention campaigns when they make intersectoral allocations of the government’s budget. Even in Thailand, however, there is no room for complacency. Although policies have been successful in lowering infection rates, prevalence of HIV in high risk groups is still high – especially among those groups that were not explicitly targeted by past prevention efforts such as IDUs or male sex workers. There is also evidence that the impact of past prevention campaigns is waning. Recent rounds of the Behavioral Surveillance Survey (BSS) show that the percentage of male conscripts reporting sexual relationships with commercial sex workers, after declining for 3 several years, has started to pick up again in 2002 and 2003. The same pattern is visible with other female sex partners and among married conscripts who have extramarital sex. Condom use among these male conscripts is not high: only 59% report consistent use of condoms with sex workers; and only 25% do so with non-regular female sex partners. New risk behaviors by other groups, such as youth, also need to be addressed. Insurance and Care Coverage for PHAs Thai health policy makers have been working to expand insurance coverage to the Thai population while ensuring the financial soundness of the government health care system. In this context, the government’s decision to finance AIDS care raises issues regarding the sustainability of the overall health care financing system and whether AIDS care should be financed in the same way as care for other health problems. There are four main health insurance schemes in Thailand, covering nearly 100% of the population: the Social Security Scheme (SSS) and Workmen’s Compensation Fund (WCF) covering formal private sector workers; the Civil Servant Medical Benefit Scheme (CSMBS) for government employees; and the “30-Baht” or Universal Coverage Scheme (UCS) for the rest of the population. The different health insurance schemes are managed independently, with different reimbursement mechanisms and separate reporting requirements for providers. The different schemes offer slightly different coverage and quality of care for PHAs. The UCS covers preventive and curative care for PHAs (treatment of all OIs), but does not cover ART nor associated testing/monitoring. Access to ART for PHAs covered by the UCS is offered under the NAPHA program, which is run as a separate vertical program under the MOPH. ART is available for all PHAs who meet the eligibility criteria and are present for treatment at their registered hospital (assuming the hospital has a treatment slot available, as in some regions of the country there are waiting lists). The patient must pay for the first CD4 test (about 500 Baht); but all monitoring and testing once the patient’s enrolled is covered by NAPHA, as well as the cost of the drugs (in practice, however, hospitals exercise some discretion in asking patients to co-pay, depending on an assessment of their means). Until August 2004, NAPHA also covered access to ART for PHAs under the SSS. As under the UCS, patients were required to pay for the first CD4 count, but all subsequent monitoring and testing, as well as the price of the ART was covered by NAPHA (although again with discretion on the part of the hospital as regards co-payments). All other OP and IP care for PHA was covered by SSS. As of August 2004, the SSS includes access to ART as part of its care package for PHAs. All SSS patients being treated under NAPHA are transferred to SSS (about 13,000). Guidelines for treatment (including the choice of drug regimes for first line treatment) are purported to be similar for SSS and NAPHA. The CSMBS covers all PHA care including ART, and associated monitoring/testing. AIDS Expenditure and Financing According to the National AIDS Accounts (Teokul, Tangcharoensathien et al., 2004), total health expenditure on HIV/AIDS increased from 2,996 million Baht in 2000 (US$74.4 million) to 4,188 million Baht in 2003 (US$101.3 million). The largest increases in spending during this period came from the ART program (which more than tripled in spending) and from Outpatient care. In 4 response to this, the share of total AIDS expenditure going to ART increased from 20.3% in 2000, to 50.1%in 2003. Jointly, ART and OI account for 85.1% of total AIDS spending. The share of spending going to prevention activities has declined sharply, from 9.3% in 2000 to 5.1% in 2003, but the level has remained roughly constant in current prices (Figure 3). Millions (USD) Figure 3: National AIDS Budget Allocation during 1996-2004 60 50 40 30 20 10 0 1996 1997 Prevention 1998 1999 2000 Treatment & Care 2001 2002 Research & Mgt 2003 2004 Global Fund Source: MOPH, National Prevention and Alleviation of AIDS Budget Allocation by the RTG. The bulk of expenditures on HIV/AIDS have been financed from public budgetary sources, which account for 65-80% of total AIDS expenditure during 2000-2003. The share of financing coming from the two main health insurance schemes, SSS and CSMBS, has remained stable at 2.5% and 3% respectively for the same period. The share of spending by SSS is expected to increase as the scheme covers ART treatment for SSS beneficiaries. Under this new SSS policy, around 13,000 patients are expected to shift from NAPHA program to SSS. Household out-of-pocket spending has also played a significant role in financing AIDS expenditures, accounting for 27-28% of total AIDS spending. Donor sources played a negligible role until 2003, when resources from the Global Fund started to kick in, raising the share of financing by external sources to about 9% of the total. II. Measuring the Impact of ART Policy The objective of ART policy is to improve the health of patients, allowing them to live longer healthier lives. But ART policy has other effects, some of which are beneficial to the patient and society, and some which are potentially harmful. A full economic analysis of ART would attach a monetary value to all of the effects of ART, whether beneficial or harmful, in order to compute the net-present value of the policy. Such an aggregated perspective is especially useful for comparing the social rate of return to investments in treating AIDS patients to investments in other sectors. The disadvantage of adopting the full economic approach lies in the fact that unit values for healthy life years, years of orphanhood and other effects of the ART policy are hard to establish or defend. Analysis based on controversial unit values will itself be controversial and this controversy may distract from points that can be made without adopting these monetary values. So in this analysis we have chosen to keep track of as many as possible of the effects of 5 ART, without attempting to aggregate them across categories. Our approach thus fits within the framework of cost-effectiveness analysis rather than cost-benefit analysis. Measuring the Effects Since the objective of ART policy is to lengthen and improve the lives of the recipients, a natural measure of the effectiveness of a policy is the number of life years it adds to the population. Since the AEM model is a difference equation model, in which individuals are subsumed into groups, it is not possible to directly measure the life years saved. The model, however, does provide a count of the number of people beginning ART at each of the two recruitment points: early and late. This report presents a calculation of the estimated number of additional life-years that accrue to each individual who begins treatment, by whether that treatment is early or late. We measure the effectiveness of an ART policy option by multiplying this estimate of per-patient life-year benefit by the number of patients initiating each type of treatment in that year. This gives a stream of annual benefits that continues over time as long as treatment itself continues. Public policymakers need to consider not only the direct effects of ART policy on the patients receiving ART, but also the indirect effects of ART on the creation of new cases of HIV infection. There is increasing evidence, for example, that ART patients are significantly less infectious than they would be in the absence of ART or with only mono- or duo-therapy. Assessing these spillover effects of ART on people other than the patient is an indispensable part of designing policy. Table 3 provides a classification of these indirect (or “external”) effects into biological and behavioral effects on transmission. Within each of these categories, the effects could be beneficial, by slowing transmission, or adverse, by accelerating it. The measure of the importance of any of these effects is the rate of new HIV infections, or HIV incidence rate. Biological Behavioral Type of effect: Table 3. Possible effects of ART on HIV transmission Direction of effect Beneficial Adverse (Slow transmission) (Speed transmission) ¤ Reduce infectiousness. ART may ¤ Select for resistance. Imperfect adherence lower viral loads and may therefore to ART selects for resistant strains of the lower the risk of transmission per virus, which can then be transmitted. sexual contact. ¤ Longer duration of infectivity. The greater longevity of HIV infected people taking ART has the unintended negative consequence of increasing the period in which the patient can transmit the virus. ¤ Encourage prevention, especially ¤ Off-setting behavior. People receiving diagnostic testing. ART may ART, and HIV positives and negatives in the increase the uptake rates of surrounding community, may engage in more prevention activities, particularly risky behaviors than they would if ART were voluntary counseling and testing. unavailable. Source: M. Over, et al. (2004). 6 Measuring the Costs Cost analysis of health programs typically distinguishes between fixed costs and variable costs. The fixed costs are occasioned by the establishment of a health program, while the variable costs are typically simply unit costs multiplied by the number of units of output. For the purposes of projecting the costs of ART policy we have adopted the simplifying assumption that most program costs will be related to the individual patient in the form of provider time, pharmaceutical products, diagnostic tests and disposable paper and rubber products, and therefore will not vary much with scale or scope. The exception we are making to this rule is the cost of equipping a health care facility that is not a district hospital with the capacity to administer ART. We assume that in order to qualify to manage one or more ART patients, any facility must train a minimum number of providers in ART protocols and, in order to keep them abreast of the rapidly changing technology of ART, must re-train those staff every year. This category of costs might be called “recurrent fixed costs”. They recur every year as a function of the number of facilities, but can be spread over all the patients at the facility. III. The Effects of Thailand’s ART Policy In order to estimate the impact of NAPHA and then the cost-effectiveness of various modifications of NAPHA, we must model how the specific changes introduced by NAPHA influence the behavior of patients and providers. Our approach is to construct a model of the links between government instruments and policy outcomes. We do this in five steps. First, we model the link from Figure 4: Policies to epidemiology to performance the two primary policy instruments, price and availability (or supply), to the Modeling: Policy to Impact distribution of patient demand for care. Second we project the POLICY INSTRUMENTS MODEL INPUTS MODEL OUTPUTS COST & IMPACT ANALYSIS evolution of prices and Demand for ART Biological HIV cases •Unit Cost Analysis availability into the future and Price Time to death Annual deaths Cost of OI treatment Distance Shifts from 1 to 2 line VCT by risk group Cost of ART compute the projected Quality Transmission reduction Sympt. on 1 line ART Cost of PHA support Supply for ART Behavioral Sympt. on 2 line ART •Cost projections Available ART slots Dropouts in each arm Asympt. on 1st line ART •Cost-effectiveness Analysis distribution of demand across Demand for VCT Risk behavior Asympt. on 2 line ART Cost per death averted Price Condom use Cost per life year saved treatment options. Third, we Distance Needle sharing •Financial Analysis Quality Impact on AIDS budget apply the expected demand to Supply for VCT Impact on health budget Prop. of pts in each arm Available VCT slots Financing No. of pts in each arm the Thai population of eligible infected people (as projected by an updated version of the Asian Epidemiological Model (AEM)) COST & IMPACT Models ASIAN EPIDEMIC MODEL SHEETS of behavior in order to deduce the future of (Proprietary AEM) (Excel) (Excel) ART utilization. Fourth, we estimate the direct and spillover effects of ART utilization on Source: Authors’ construction. health and HIV incidence; and fifth we apply unit costs to estimate the financial burden of the NAPHA policy. These five steps are summarized in Figure 4. st nd st nd nd 7 Projection Scenarios The impact of a policy choice can only be defined in comparison to what would have happened in the absence of this choice. This alternative scenario, called a “baseline” or “counterfactual”, is a projection of the future course of AIDS treatment had the Royal Thai government not introduced its expanded NAPHA program. There were several alternative baseline scenarios that could have been chosen (cells (a), (b) and (c) in Table 4), each corresponding to a different combination of public financing of ART and government subsidization of the production and sale of low-cost ART. The chosen baseline corresponds to cell (a): what would have happened had the government kept only its previously existing (pre-2001) voluntary program, with only branded drugs available. The impact of NAPHA is obtained by comparing outcomes from cell (a) to those from cell (d). The total impact could be separated into a part due to the availability of low-cost generic ART and a part due to the public finance of ART provision. Such a deconstruction would enable us to attribute portions of the benefits of NAPHA to each of its two components and a portion to synergy between them. We do not undertake that deconstruction here. Table 4: Potential baseline scenarios or “counterfactuals” to NAPHA No Govt. to produce and sell low-cost ART (GPO-vir) Yes Government to finance ART publicly No (private out-of-pocket only) Yes (a) Baseline. No government (b) Provide subsidized public intervention – voluntary program production with no possibility only, too small to make a of alternative supply channels difference (buyers clubs etc) (c) GPO produces and markets GPO-VIR at current prices (less than $1/day), but government does not expand public delivery of ART through the public health system beyond the ATC program (d) NAPHA (current form and alternative versions including stimulating VCT for earlier recruitment, and introducing demand-side incentives to increase adherence) In addition to the NAPHA policy scenario described above, the report considers two enhancements to NAPHA and a third policy which would combine these two enhancements (Table 5). The enhancements are chosen to address what are perceived by knowledgeable Thai and international observers to be potential weak points in the NAPHA program and indeed in all publicly financed and provided ART programs worldwide. Early analyses of the effectiveness and cost-effectiveness of publicly provided ART assumed that many HIV-infected patients would be recruited to treatment when their immune systems first drop below an eligibility threshold, so that the benefits of ART would be maximized. Experience in Thailand as well as in several other countries (e.g. Malawi, Botswana, Brazil, and OECD countries) shows, however, that the vast majority of patients are identified as ART eligible only when their opportunistic illnesses lead them to the hospital, when their CD4 counts are already well below the threshold at which they would most benefit from care. It is thus useful to analyze an alternative version of NAPHA which would include a much more vigorous promotion of 8 voluntary counseling and testing (VCT) in an effort to attract patients into treatment when they first become eligible for it. A major challenge for ART programs will be to attain and sustain high levels of adherence among their patients. Ministry-sponsored training programs for public sector ART providers are currently teaching the importance of adherence. But experience around the world suggests that, as ART treatment is scaled up, it will be increasingly difficult to attain high levels of adherence among new patients and to sustain them among all patients. One promising approach with which Thailand has already experimented is to subsidize, and to facilitate the organization of, NGOs that provide emotional, physical and sometimes even financial support to patients. In this report, we refer to public sector delivery which has been strengthened by the addition of these “demand enhancing” programs as “augmented public” delivery of ART. Our “Augmented (D3)” scenario is intended to capture the incremental benefits and costs of such a program. We also model a “Both (D4)” program, which includes the costs of both expanded VCT and “augmented” adherence and models a synergistic benefit between them. Table 5. Policy scenarios for the NAPHA program Encourage adherence through demand-side incentives such as PHA groups, accompagnateurs, conditional transfers, etc. No Yes Encourage VCT and early recruitment into ART No Yes (D1) Current implementation (D2) Earlier recruitment of NAPHA program through VCT (at higher CD4 (recruitment of mainly counts), without improved symptomatic HIV through adherence the public health system) (D3) Improved adherence (D4) Improved adherence without earlier recruitment and earlier recruitment (keep current recruitment of (recruit earlier through VCT symptomatic HIV via public at higher CD4 counts) health system) The Asian Epidemic Model The Asian Epidemic Model (AEM) is a difference equation model that projects the dynamic patterns of HIV epidemics in Asian settings. Developed by Tim Brown and Wiwat Peerapatanapokin of East-West Center, in collaboration with the Thai Epidemiological Working Group and the Thai Ministry of Health, the model is sufficiently disaggregated to benefit from available data on risk behavior and HIV prevalence of all the important risk groups within the Thai population (The Thai Working Group on HIV/AIDS Projection 2001; Brown and Peerapatanapokin 2004). The model has three major transmission modules (heterosexual contact, needle sharing and homosexual contact) and eight risk groups. The biological parameters of the model have been calibrated so that the model’s projected prevalence rates match observed rates by risk group.2 Such detailed fitting is rare among models of HIV epidemics partly because most countries outside Thailand have too little data to permit such comparisons. 2 This is the meaning of the term “semi-empirical” that the published papers use to describe the model. 9 The previous version of this model did not include the effects of ART on the longevity of people with HIV, on their likelihood of transmitting HIV or on the development and spread of drug resistant strains of the virus (The Thai Working Group on HIV/AIDS Projection 2001). The new version of the model, developed for this report, allows for: (a) detailed modeling of early VCTbased recruitment of asymptomatic patients (at higher CD4 counts) to increasingly substitute for late recruitment of symptomatic patients through the health system (typically at much low CD4 counts); (b) different treatment arms (pure public vs. augmented public vs. private); and (c) progression into second line therapy (Brown and Peerapatanapokin 2004). IV. Costs and Resource Needs for ART Costs of ART can be defined in many ways, such as costs to the public sector, to individual patients, and to the society. In order to evaluate the various policy options for expanding public provision of ART in Thailand, we adopt the perspective of and estimate the costs to the public sector. Average costs of ART per patient are estimated based on types of treatment regimes (first line therapy and second line therapy), modes of service delivery (public, augmented public and private service delivery), and stages of the disease (asymptomatic and symptomatic HIV). Specific cost components included in estimating average costs of ART per patient are: ARV drugs, lab tests and monitoring; treatment of OIs; and PHA support. Cost data were obtained from existing studies in Thailand, both published and unpublished, and informal consultations with local and international experts. Costs of ARV drugs and monitoring Table 6 summarizes costs of various regimens currently available and recommended by Thai MOPH and WHO in their treatment guidelines. The annual costs of ARV drugs vary significantly between first line and second line regimens, ranging from 14,400 baht (using GPO-vir) to 273,864 baht (using expensive PIs) per patient per year. The average cost of first line ART regimen is estimated at 19,271 baht (US$ 481.8) per patient per year, using weighted average of three categories of ART drug regimes under the MOPH treatment guideline. 3 The average cost of second line regimen is estimated around 270,000 baht (US$6,740) per patient, costing 14 times more than the average cost of first line regime. 3 Weights are distributed by 80%, 15%, 5%, for (1), (2), and (3) ART regimes respectively. 10 Table 6. Costs of ARV drugs per patient by types of regimens in Thailand (1USD = 40 baht) Monthly Cost Annual Cost ARV drugs Baht USD Baht USD First line regimens (MOPH guideline) (1) 3TC+d4T+NVP 1,200 $30.0 14,400 $360.0 2,579 $64.5 30,948 $773.7 (2) d4T+3TC+EFV AZT+3TC+EFV 3,819 $95.5 45,828 $1,145.7 AZT+3TC+NVP* 2,400 $60.0 28,800 $720.0 (3) d4T+3TC+IDV/r 3,500 $87.5 42,000 $1,050.0 AZT+3TC+IDV/r 4,740 $118.5 56,880 $1,422.0 1,606 $40.1 19,271 Average cost $481.8 Second line regimens (WHO guideline) ABC+ddI+LPV/r 22,822 $570.6 273,864 $6,846.6 ABC+ddI+SQV/r 22,094 $552.4 265,128 $6,628.2 22,458 $561.5 269,496 Average cost $6,737.4 Source: Bureau of AIDS, TB, and STI, MOPH, 2004. Duncombe, C. (2004) Section Two in the Clinical Background Paper, 2004. The Government Pharmaceutical Organization, Price List, 2004 Note: Costs of ARV drugs are based on the lowest prices available (either generic or branded drugs) in Thailand, as of September 2004. * The GPO is currently in the production process of a fix-dose combination of GPO-Z (AZT, 3TC, and Navirapine). The cost of GPO-Z is approximately at 1400 baht (US$35) per month. In addition to the cost of ARV drugs, there are significant costs associated with the provision and monitoring of ART treatment. The costs of outpatient and inpatient services are not negligible as utilization of medical services increases at the time of initiating ART treatment. A recent study4 evaluating medical resource utilization for ART estimated that the average cost of hospital services (including OPD and IPD services, but excluding ARV drugs, lab tests, and OI medications) is around 7,700 baht (US$193) per patient per year in public hospitals, ranging from 12,850 baht (US$321) in university teaching hospitals to 5,340 baht (US$134) in community hospitals (Supakakunti, Phetnoi et al. 2004). The cost of CD4 test by standard flow cytometry varies from 200 baht to 800 baht with the median cost of 500 baht (US$12.5), depending on the institution and the volume of testing. The cost of HIV RNA (viral road) test is significantly higher, averaging at around 3,500 baht (US$88) per test. A basic safety chemistry panel (SGOT, creatinine, glucose) costs around 100 baht (Duncombe 2004 and Gold 2004). In addition to the routine monitoring tests, patients incur sets of screening tests (i.e., CD4 count and HIV antibody) prior to initiation of ART treatment. These initial screening tests cost around 1,100 baht (US$28) per patient. Costs of OI treatment Prior to the introduction of the NAPHA program, treatment for OIs comprised the bulk of treatment cost in national AIDS expenditure. More than 20 different infections are associated with severe immune depletion. Even though the costs of OI treatment vary significantly 4 The study was conducted, jointly by WHO-Thailand and the Center for Health Economics at Chulalongkorn University, at 32 public hospitals across 4 regions in Thailand to evaluate economic costs associated with NAPHA program. The study specifically followed 380 patients between October 2002 and December 2004 to measure the medical resource utilization at public hospitals. 11 depending on the type of infections and available treatment options, there are several types of infections observed most often among symptomatic HIV patients. The OIs that are commonly observed in Thailand are tuberculosis (TB), pneumocystis carinii pneumonia (PCP) cyriptococcal meningitis, cytomegalovirus infection and others (Ratanasuwan, 2004; Supakankunti, et al. 2004). Existing studies on OI treatment from Thailand were reviewed to estimate the average cost of OI treatment per patient. The average costs of OI treatments vary across the studies, ranging from $64 to $206, with the average cost of $151 per patient. Costs of PHA groups PHA groups have long played a major role in providing care and support needed for HIV patients in Thailand. Many of the public hospitals under the NAPHA program work with PHA groups who provide counseling, information, home visits and other supports to PHAs. It is expected that continuous care and support from PHA groups will become increasingly important in expanding public provision of ART; specifically by supporting patients in their adherence to ARV. Success of community involvements in HIV/AIDS care through PHA groups and community based organizations has been well documented in Thailand, while very little has been studied about their resource requirements and financial sustainability. With the help of MSF-Thailand, and drawing on their experience with PHA support groups nationwide, we obtained some preliminary estimates of the costs of PHA support to improve adherence. These estimates suggest that providing PHA support to improve adherence costs approximately 3,100 baht (US$78) per patient; or in other words, adds some 8-9% to the total cost of ART per patient per year (Masaki, 2004; interview with David Wilson, MSF). Average cost of ART per patient Based on the above estimates, the annual average cost of ART using first line therapy is estimated at around 33,000 baht (US$825) per patient (Table 7). The costs of ARV drugs and lab monitoring represent nearly 60% of the total ART cost when first line therapy is used, and increases to 95% of the ART costs when patients are on second line therapy. Table 7. Annual cost per patient by types of drug regimens Annual Cost per patient Cost Items (1) ARV drugs (2) Lab tests (3) OI treatment (4) OPD service (5) IPD service (6) ARVs + lab tests (7) Hospital services (8) Total ART cost (1) + (2) (4) + (5) (3)+(6)+(7) 1st line THB USD 18,847 $471.2 1,210 $30.3 4,815 $120.4 2,773 $69.3 6,041 $151.0 20,057 $501.4 8,815 $220.4 33,688 $842.2 2nd line THB 263,567 1,210 4,815 2,773 6,041 264,778 8,815 278,408 USD $6,589.2 $30.3 $120.4 $69.3 $151.0 $6,619.4 $220.4 $6,960.2 Source: Supakankunti, et al. (2004). Costing of “The National Access to Antiretroviral Programs for People living with HIV and AIDS” in Thailand. Chulalongkorn University and WHO, Thailand. Note: The presented cost per patient is an average cost of provincial and community hospitals. 12 V. Main Findings 1. NAPHA is cost effective and yields large benefits in terms of life-years saved. • By the year 2015 the NAPHA policy will have added about 220,000 people per year to the living population. Even at the end of the projection horizon, when the Thai AIDS epidemic is predicted to slow, the NAPHA policy will be saving about 190,000 life years each year (Figure 5). By keeping people alive longer, NAPHA will be associated with an increase in the number of HIV infected people in Thailand, and with a significant increase in the number of PHAs on treatment. • The total cost of NAPHA with second line reaches a ceiling at US$500 million per year in 2020. Beginning in 2010, expenditures on second line start to account for more than one-half of total spending. By the end of the projection, second line therapy for one quarter of all the patients is absorbing three-quarters of the treatment budget (Figure 6). • At a conventional discount rate of 3%, the cost per life year saved for the NAPHA policy is $2,144, only slightly greater than Thailand’s 2002 gross national income per capita of $2,000. • NAPHA with first-line only is more affordable and more cost-effective, but also yields significantly lower benefits in terms of life-years saved (Figure 7). 13 Figure 5: Benefit (Life Years Saved) and Costs of NAPHA relative to Baseline (Costs are in millions of 2004 US dollars) LYS 250,000 ART Cost (net) and Benefit (LYS) in Scenario D1 - Compared to Scenario A - in million 600 500 200,000 400 150,000 LYS 300 Net Cost of ART 100,000 200 50,000 100 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 0 Figure 6: After 2010, most costs are for second line therapy (Millions of US$) Millions Total Cost of Public ART (NAPHA) 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 $500 $450 $400 $350 $300 $250 $200 $150 $100 $50 $0 Cost of Public ART_1 line_asy Cost of Public ART_2 line_asy Cost of Public ART_1 line_sym Cost of Public ART_2 line_sym 14 Figure 7: Program with first line only is more cost-effective NPV of Cost per LYS by Scenario - discounted at 3% $3,000 $2,500 $2,000 $1,500 $2,145 $1,000 $500 $736 $0 NAPHA_1only NAPHA_1only NAPHA_1+2line 2. Expanded policy options increase life years saved (LYS) but are slightly less-cost effective • Adding early recruitment and enhanced adherence buys additional life years. The expanded VCT, augmented adherence and “Both” policies would save respectively 18,000, 50,000 and 60,000 additional life years in 2020, on top of the 210,000 LYS generated by NAPHA alone. Thus for the year 2020, the alternative policies offer the possibility of improving the benefits by almost 30 percent (Figure 8). • These expanded policies, however, also involve additional costs. Of all four policies, the current NAPHA policy (D1) is the most cost-effective. The second most cost-effective is the Augmented policy. This is not surprising since it achieves two or three times as many incremental life-years saved at roughly the same cost as the VCT scenario. Because it combines the two “pure” enhancement strategies, the cost per year of the “Both” scenario lies between the costs per year of the other two scenarios (Figure 9). 15 Figure 8: Projected Annual LYS under Alternative Scenarios relative to baseline) Additional LYS 300,000 250,000 200,000 150,000 100,000 50,000 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 0 Scenario D1 Scenario D2 Scenario D3 Scenario D4 Figure 9: Cost Effectiveness of NAPHA and alternative scenarios relative to Baseline NPV of Cost per LYS by Scenario - discounted at 3% $3,000 $2,600 $2,342 $2,200 $2,145 $2,184 $2,243 $1,800 $1,400 $1,000 Scenario D1 D1 ScenarioScenario D2 Scenario D3 Scenario D4 3. Public financing will help assure equitable access to ART for poor patients • Suppose that Thailand had reduced the price of first-line ART, by authorizing the production of GPO-Vir, but had refrained from subsidizing treatment. For the top half of the households in the income distribution, first-line ART could be affordable via user fees (Figure 10). Even for the poorest half of the households, the $842 cost of first-line therapy compares with the medical expenses of the sickest households for a single year. 16 The problems for the poorest households are likely to be caused by two unusual features of the cost of treatment. First, it must continue for the rest of the patient’s life. For households in the lowest 80 percent of the income distribution that might be able to raise the resources to pay the $842 for one year, the second and third year will become increasingly onerous. Second, laxity in treatment will lead to treatment failure, the development of resistant strains of the virus, the spread of those resistant strains to others and the requirement that the patient move to second-line therapy. • While it is conceivable that the cost of first-line therapy could be partially financed with user fees, second-line therapy is much more expensive, exceeding total household income for forty percent of the population. A large proportion of those on first-line therapy will eventually need second-line therapy, and would not be able to afford it without public support. Figure 10: Affordability of ART by Income Level Affordability by Income Lev els $45,000 $40,000 Mean household incom e Nonfood expenditure per household Medical expenditure per household Cost of ART (2nd line) $35,000 $30,000 $25,000 $20,000 Cost of ART (1st line) $15,000 $10,000 $5,000 $0 Q1 Q2 Q3 Q4 Q5 Income Ouintile 4. Public financing can strengthen positive spillovers and limit negative spillovers of ART • ART may be used to increase the uptake rate for prevention activities, especially voluntary counseling and testing. But this requires greater integration of treatment and prevention efforts that currently exists in Thailand. • Poor adherence to first-line therapy will speed the development of resistance to those drugs and hasten the day when the patient must move to second-line therapy. Public intervention to support adherence can limit the spread of resistance virus. From a social as well as an individual perspective, adherence support mechanisms such as the “augmented” public care we model in this report are likely be cost-effective as well as therapeutically beneficial. 17 5. If the success of ART rollout makes people or the government complacent about prevention, future costs could rise substantially. • If the availability of ART leads people to reduce risk behaviors such as drug injecting and unprotected sex, the cost-effectiveness of ART is improved by about 9 percent and future government expenditures on ART will go down by $926 million dollars or by 14 percents. • On the other hand, if the availability of ART leads people to increase their risk behavior back to its levels in the early 1980s, the cost per life year saved will triple from $2,145 to $6,243 (from 85,800 baht to 249,720 baht). There will be a similar increase in future government expenditures. 6. Future government expenditures on ART and the lives it will save are highly sensitive to negotiated agreements on the intellectual property rights for pharmaceuticals • Since the drugs used in second-line therapy are patented, produced and sold by multinational pharmaceutical corporations, Thailand must either pay the high prices demanded by those monopolies or exercise its rights under World Trade Organization treaties to grant a “compulsory license” for the manufacture of the drug subject to negotiated royalties. • Because Thailand stands to gain a great deal from bilateral agreements to reduce trade barriers with trading partners like the United States, the RTG may be tempted to relinquish its rights to grant compulsory licenses for AIDS drugs in exchange for proffered trade advantages. The report finds that the cost of such concessions would be large. For example, by forgoing compulsory licensing to reduce the cost of second-line therapy by 50%, the RTG would raise the cost per life-year saved of the NAPHA program by 45% (from $1,476 to $2,145) and increase its future budgetary obligations by 1.8 billion discounted dollars (71 billion discounted baht) through the year 2025. • The size of royalty payments that the WTO mandates to accompany compulsory licensing is indeterminate and subject to negotiation. Thailand could enhance its bargaining power by coordinating its negotiations with other middle and low income countries. VI. Conclusions and Recommendations • In its current form, Thailand’s NAPHA program is affordable. Under the model’s assumptions it is also cost-effective. Furthermore, although the two enhanced policies we suggest (early recruitment through expanded VCT and improved adherence via PHA groups) are less cost-effective, they are still a good bargain, particularly if BOTH are enacted. • Much of the cost of ART over the long-term is associated with provision of second line treatment. One way to limit the potential financial burden is for the Thai government to make explicit the scope of its commitment to providing public ART: is it a limited commitment to provide only first-line treatment, or a more open commitment to provide whatever level of treatment is required by the patient? Estimates of cost-effectiveness 18 show that a version of NAPHA that includes only first-line drugs is much more costeffective, at only $736 per life year saved, than the policy with second line; however, NAPHA with second-line saves many more life years. • A second way for the RTG to limit its expenditures on second-line therapy is to grant compulsory licenses for the manufacture of patented second-line pharmaceutical products. Doing so will require high-level political resolve based on an accurate understanding of the costs to Thailand of trade concessions on this issue. • Although affordable, expanding ART represents a long-term financial commitment that must be integrated into the budget processes. Once the Thai government has committed to starting a patient on ART, this becomes an entitlement that cannot be sacrificed to budget cycles without incurring large negative externalities. Sustaining the program will require a significant increase in the total health budget, to avoid other health programs being squeezed by ART. Alternatively, the Government may need to explore other financing mechanisms – including greater use of health insurance schemes. • Although NAPHA may be affordable, Thailand must be careful to maintain quality management as it scales up and to sustain that quality over twenty years. This is a very long run commitment. • The biggest challenge for Thai policymakers will be how to resist complacency and instead build a synergistic relationship between treatment and prevention. This may require devolution of responsibility for both treatment and prevention to provinces or below so that government units that succeed with prevention will benefit from the saved treatment costs. • Finally, the cost of $2,145 per life year saved through ART may be much more than Thailand would have to spend to save life years with other interventions. The study recommends that Thailand accompany its expansion of the ART program with vigorous investigation of other promising opportunities to improve health cost-effectively. Prime candidates among these alternatives would be inexpensive HIV prevention programs, including condom distribution and peer education. To our knowledge, no study of the cost-effectiveness of condom distribution has ever been done in Thailand. Expansion of immunization programs, of traffic safety and trauma management, of nutrition programs and of water supply are all candidates for cost-effective interventions which would save life years at probably much less than $2,000 per year. 19 REFERENCE Brown, T. and W. Peerapatanapokin (2004). Adding HAART to the Asian Epidemic Model, presentation at the Workshop on "Expanding Access to ART in Thailand: achieving Treatment Benefits and Promoting Effective Prevention". Bangkok, Thailand. Brown, T. and W. Peerapatanapokin (2004). 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